Phase 2, Multicenter, Randomized, Parallel, 3-arm, Placebo-controlled Study to Assess Efficacy and Safety of CDR132L in Patients with Reduced Left Ventricular Ejection Fraction (<= 45%) After Myocardial Infarction (HF-REVERT) - CDR132L (Cardior)

IQVIA Biotech0 个研究点目标入组 38 人开始时间: 待定最近更新: 2024年4月9日

适应症

试验速览

阶段: 2 期
状态: 尚未招募
发起方
入组人数: 38

研究概览入排标准研究者记录与标识符相似试验

研究概览

简要总结

暂无简介。

研究设计

研究类型: Interventional

入排标准

年龄范围: 18 至 99（—）

入选标准

•1. Male or female of non-childbearing potential patients, aged >= 30 to <= 80
•years at the date of signing informed consent which is defined as the beginning
•of the Screening Period.
•2. Spontaneous AMI (type I) based on the universal MI definition with
•randomization to occur no later than 14 days after index event diagnosis.
•3. Patient with a LVEF <= 45% as measured by ECHO after MI diagnosis (STEMI or
•4. Patient with NSTEMI with evidence of significant myocardial necrosis,
•evidenced through a troponin T or troponin I increase to at least 5 times the
•upper limit of normal (ULN) at MI index event diagnosis.
•5. Patient with previous MI events in history can be included.
•6. A male patient must agree to use contraception as detailed in Appendix 5 of
•this protocol during the treatment period and for at least 30 days after the
•last dose of study treatment and refrain from donating sperm during this period.
•7. Patient with body weight of <= 120 kg.
•8. N-terminal pro B-type natriuretic peptide level >= 125 pg/ml and < 8000 pg/ml.
•Note: NT-proBNP values required for eligibility confirmation may be collected
•at any time post MI either through medical history (e.g., site has collected it
•as SoC once the patient came to the hospital), through a local laboratory
•assessment, or by sending a sample to the central laboratory (if sites use the
•SoC sample or the local laboratory sample for eligibility confirmation, no
•additional sample for central laboratory assessment is needed).
•9. Patient with STEMI/NSTEMI who underwent percutaneous coronary intervention
•or angiography (if no indication for stent placement or balloon procedure) for
•this event.
•10. Capable of giving signed informed consent as described in Appendix 2 of the
•protocol, which includes compliance with the requirements and restrictions
•listed in the informed consent form (ICF) and in this protocol.

排除标准

•1.A woman of childbearing potential (WOCBP) as defined in Appendix 5. 2.Patient
•with HF of non-ischemic origin; e.g., myocarditis, alcoholic cardiomyopathy.
•3.Patient with history of decompensated HF or a history of LVEF <30% within 6
•months prior to MI Index event. 4.Patient with NYHA class IV at screening or
•randomization. 5.Patient has any planned cardiac intervention (angiogram
•without angioplasty is acceptable) or any other planned surgery after the
•Screening Period. 6.Patient has severe valvular heart disease. 7.Patient has
•systolic BP < 90 mmHg or > 180 mmHg, diastolic BP < 50 mmHg or > 110 mmHg,
•and/or heart rate < 50 or > 100 beats/minute at screening or randomization.
•8.Patient with an estimated glomerular filtration rate < 30 mL/min/1.73 m2 or
•on dialysis. 9.Patient with hepatic insufficiency classified as Child Pugh B or
•C. 10.Patient with known active human immunodeficiency virus, Hepatitis B, or
•Hepatitis C infection at screening. 11.Impaired hepatic function defined by a
•total bilirubin level of >= 2 × the ULN and ALT levels of >= 3 × ULN. 12.Patient
•has medical history of disease(s) affecting the blood-brain-barrier, e.g.,
•stroke within 6 months or multiple sclerosis. 13.Patient has medical history of
•bleeding disorders or has thrombocytopenia (platelets < 100,000/µL). 14.Patient
•has poorly controlled diabetes as determined by the Investigator. 15.Patient is
•currently on treatment for epilepsy. 16.Patient has a current or relevant
•history of physical or psychiatric illness that is/are not stable or may
•require a change in treatment, use of prohibited therapies during the study, or
•cause the patient to be unlikely to fully comply with the requirements of the
•study or complete the study, or any condition that presents undue risk from the
•study drug or study procedures. 17.Patient has a history or presence of any of
•the following cardiac conditions: known structural cardiac abnormalities beyond
•HF, family history of long QT syndrome, cardiac syncope, or recurrent,
•idiopathic syncope. 18.Any clinically significant abnormalities, at the
•discretion of the Investigator, in rhythm, conduction, or morphology of resting
•ECG that pose an additional safety risk to patients. This will include patients
•with any of the following (at Screening Visit or Day -1): a)Clinically
•significant PR (PQ) interval prolongation. b)Intermittent second- or third
•degree atrioventricular block. c)Sustained cardiac arrhythmia including (but
•not limited to) supraventricular tachycardia, any symptomatic arrhythmia with
•the exception of isolated extra systoles. 19.Patient with active and
•clinical-relevant *severe acute respiratory syndrome coronavirus 2
•(SARS-CoV-2)* infection confirmed as per the local testing guidelines at
•screening. 20.Patient has other significant disease or disorder which, in the
•opinion of the Investigator, may put the patient at risk because of
•participation in the study or may influence the result of the study or the
•patient's ability to participate in the study. 21.Patient has received an
•investigational product or treated with an investigational device within 90
•days prior to first study drug administration. 22.Patient has known or
•suspected intolerance or hypersensitivity to the study drug, any closely
•related compound, or any of the stated ingredients. 23.P

研究者

发起方

IQVIA Biotech

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